SFM

I2VS

What is it?

DIR’s I2VS is the first in industry 100% in-line inspection system for induction sealed bottles and jars that is non-intrusive and does not result in production slowdown. A quantum leap from sampling to monitoring every single package – the system goes a step further to provide process control by indicating not only if an issue occurs, but what caused it, giving the opportunity to amend in real time.

How does it work?

The I2VS combines high end thermal imaging normally used in the defense industry with sophisticated analysis algorithms and proprietary IP to provide real time integrity monitoring of every single bottle on the packaging line – at the speed of the machine throughput. Inspection is “hands off”, non-invasive and non-destructive. Nothing is projected at the product; the I2VS reads and analyzes the inherent heat signature of the cap’s liner (which is amplified directly after induction). The I2VS is compatible with most bottle and caps sizes and types and can be easily integrated in to almost any packaging line.

DIR Eye

What is it?

The DIR Eye is the first 100% in-line inspection system for heat sealed packages that is non-intrusive and does not result in production slowdown.

A quantum leap from sampling to monitoring every single package – the system’s real time analysis provides insight in to the quality of the sealing process, enabling operators to detect and immediately amend issues should

How does it work?

The DIR Eye combines thermal imaging technology with sophisticated analysis algorithms to provide real time integrity monitoring of every single package or container on the packaging line – at the speed of the machine throughput.

Inspection is “hands off”, non-invasive and non-destructive. Nothing is projected at the product; the DIR Eye reads and analyzes the inherent heat signature of the seal (which is amplified directly after the sealing process).

The DIR Eye is compatible with different package sizes and types and can be easily integrated in to almost any packaging line.

SFM

What is it?

DIR’s SFM is the first in industry 100% in-line inspection system that provides: 1. Full monitoring of sachet sealing integrity and 2. Content monitoring of fill levels including identifying an empty or incorrectly filled sachet. The SFM offers a quantum leap from sampling to monitoring every single sachet, enabling issues to be discovered and fixed in real time. The SFM is non-intrusive and does not result in production slowdown.

How does it work?

The SFM combines thermal imaging and sophisticated analysis algorithms to provide real time integrity inspection of every single sachet on the packaging line – at the speed of the machine throughput. Inspection is “hands off”, non-invasive and non-destructive. Nothing is projected at the sachet; the SFM reads and analyzes the inherent heat signature of the sachet seal itself (which is amplified directly after heat sealing). The SFM can monitor most sachet laminates and most contents: powder, gel, liquids, cream etc. Sachet line length or width is not an SFM limitation. The SFM can be acquired as an integrated option in Mediseal sachet machines.

Research for the future

DIR R&D is directed at the uncharted waters of high-end thermal imaging solutions for the pharmaceutical industry with the goal of creating innovative, new ways of leveraging premium technology to help protect public health and safety.

Technology

Thermal imaging

All objects have a certain temperature and emit waves of energy, invisible to the naked eye, called infrared radiation (IR). Generally speaking hot objects emit more energy than cold objects. A thermal imager creates a viewable image from the IR waves, showing a “heat picture” of a scene.

Thermal imaging for inspection

Thermal imaging is used for inspection in a variety of industries due to the ability to detect what would otherwise be invisible, in a non-intrusive, non-destructive manner.

Thermal imaging technology was originally developed for the defense industry and is used for military and security applications. Common applications of thermal imaging include non-intrusive inspection of plumbing, electrical systems and insulation. Thermal imaging is also used by firefighters to find, for example, trapped people in smoke-filled buildings, as well as in commercial aviation, ensuring precision approaches and safe landings in reduced visibility conditions such as night, thick fog, smog, heavy rain and snow.

Dynamic Infra-Red for the pharmaceutical industry

Despite strict quality assurance guidelines and regulations, outdated packaging line inspection and quality control methods still permeate the pharmaceutical industry – making it ripe for the change DIR Technologies offers.

DIR Technologies harnesses a highly specialized part of the infra-red spectrum to create ultra-sophisticated, powerful infra-red cameras. Combined with high-speed image analysis, these enable DIR to provide unique and revolutionary monitoring and detection applications for the pharmaceutical industry and in particular, pharmaceutical primary packaging.

A quantum leap from sampling to monitoring every single package, DIR’s flagship solution, the I²VS is the first-in-industry, 100% in-line inspection system for induction sealed bottles that is non-intrusive and does not result in production slowdown. The system goes a step further, providing process control by indicating not only if an issue occurs, but what caused it, affording the opportunity to amend issues in real time. This process analytical technology (PAT) for the induction sealing process puts previously unavailable capabilities in the hands of pharmaceutical manufacturers and packaging suppliers.

DIR has recently expanded the product portfolio to also include inspection solutions for non-pharmaceutical packaging.

Market Need

Sealed means safe

The USA Code of Federal Regulations stipulates that pharmaceutical primary packaging must be sealed to ensure the integrity (quality) of the drug product as well as the safety of the consumer.

CFR 211.94 b: “Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.”

And CFR 211.132: “A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.”

Primary packaging is a vital element in the pharmaceutical manufacturing process and one that directly affects the drug being offered, its shelf-life and efficacy.

This raises the issue of testing; how can the manufacturer, dedicated to best quality, consumer safety and of course adhering to all the relevant guidelines and regulations, verify that 100% of packages coming off the production line are sealed to the standard that is needed for that particular product?

Sampling isn’t enough.

Sampling is the standard testing method today.

This method is limited in that it cannot detect discrete sealing discrepancies that can occur due to:

defects in the raw material – bottle or liner

problems in capping – false torque or crooked cap

problems with the induction sealer – alignment, field fluctuations etc.

Sampling cannot provide reliable insight in to the quality or stability of the sealing process.

A high degree of process understanding enables line operators to not only detect problems but to prevent them from occurring in the first place. This and the understanding that quality cannot be tested into products but should be built-in by design are at the core of the FDA’s PAT Initiative.

Sampling as a testing method is not chosen for its efficacy. It is the standard method used today simply because no better method was available. Until now.

100%, in-line inspection

DIR leverages premium thermal imaging combined with sophisticated analysis algorithms to enable 100% in-line inspection. This highly sensitive, completely passive technology offers a quantum leap in quality assurance and process control - the transition from sampling to inspection of every single package.

DIR’s Induction Integrity Verification System (I2VS) inspects each package, through the closed cap, at the speed of the machine throughput. There is no interference or degradation of the product – nothing is projected at the package, the I2VS reads analyzes the inherent signature of the cap’s liner (which is amplified directly after induction).

In addition, the source of any faulty seals (i.e. damaged bottle, liner, etc., or an issue in the sealing process such as torqueing or capping), is indicated in real time, which provides a high degree of process understanding and enables operators to not only fix problems immediately, but prevent them from occurring in the first place.

About DIR Technologies

Our Vision

Vision

DIR Technologies was born from the idea of utilizing high-end infra-red technology dynamically, with focus on the pharmaceutical industry.

Premium infra-red imaging or thermography is commonly used in the defense industry for night-vision, “smart” missiles and rockets etc.

DIR Technologies founders Eran Sinbar and Yoav Weinstein envisioned leveraging superior, battlefield proven technology to make the world a safer place. The pharmaceutical industry has a direct and deep impact on health and safety. Ironically, despite strict quality assurance guidelines and regulations, severely outdated inspection methods still permeate the pharmaceutical industry – making it ripe for the change DIR Technologies offers.

Dynamic solutions

DIR Technologies has developed first-in-industry thermography based inspection solutions for pharmaceutical quality assurance and process control.

The company introduced its first solutions in 2013 in the form of inspection and analysis systems for primary pharmaceutical packaging. DIR solutions offer a quantum leap from commonly used methods of sampling by providing 100% in-line, non-intrusive inspection that does not result in production slowdown.

DIR’s Induction Integrity Verification System, or the I2VS draws on proprietary, patent pending technology to inspect the integrity of induction sealed bottles. The I2VS monitors the induction process itself, providing insight on its stability and empowering the operator with the ability to detect and amend issues in real-time.

The I2VS checks 100% of packages without reducing line speeds. Thermal imaging not only allows inspection to be done through the closed cap without damaging or degrading the product, but also allows for the collection of precision data regarding overall process quality. The unit’s sophisticated algorithms enable swift, in-line analysis of data, an immediate accept/reject of bottles and, when a faulty bottle is detected, an indication of why the problem occurred.

Similarly the SFM, DIR’s Sachet Full Monitoring system, draws on thermal imaging to monitor sachet sealing integrity and content levels. The SFM can monitor most laminated sachets and most contents: powder, gel, liquids, cream etc. Sachet line length or width is not an SFM limitation.

Primary packaging sealing integrity is critical in ensuring product viability and shelf life. Leaking sachets that previously went undiscovered can now be stopped before they reach the market. Contamination can be prevented, protecting the health and safety of end users. DIR provides unprecedented insight on the sealing process of both induction sealed bottles and sachets, putting previously unattainable options and control in the hands of line managers.

Dynamic people

The DIR team was assembled with excellence in mind – each member was carefully chosen, not only for expertise, in his or her own field but also for dynamic personalities and collective synergy. Innovation and daring to think differently combined with deep professional knowledge is what sets the DIR team apart.

The team includes some of the premier thermography oriented minds in the world. Originally, most of DIR’s top executives served in key positions at SemiConductor Devices SCD, one of the world’s largest manufacturers of advanced infrared sensors – providing DIR with a solid technological basis and the ability to transition infra-red applications to the pharmaceutical world.

Management

Roni Mansur

President & CEO

Roni is a financial expert and a highly experienced manager and board member. He brings to the table an unusual combination of being comfortable in two worlds: that of statistics and accounting as well as that of entrepreneurship and out of the box thinking.

Roni served as CFO of SCD, SemiConductor Devices for over two decades. During that time he was involved in M&A activities. Roni co-founded CyOptics Inc. and served as a board member for over 12 years. Founded in 1999, the company was acquired in 2013 for $400m.
Before SCD, Roni held several financial positions in Kulicke & Soffa Ltd. and Elscint Ltd.
Roni holds a B.A. in Economics and Statistics from Haifa University and a M.Sc. in Industrial Management from the Technion.

Erez Aharonov

VP R&D,

Erez is an accomplished manager with more than 10 years of experience in the bio-medical industry.

He has led a variety of multidisciplinary programs to successful product development and product management. As Program Manager at Roche Diagnostics, Erez managed a project aimed to deliver an innovative insulin pump to the market. Erez served as R&D director for ASI, leading its R&D team as well as a global project for the American market, from development through implementation and customer acceptance.
Erez holds a B.Sc. in computer engineering and an MBA from the Technion, Institute of Technology in Haifa, Israel.

Amir Eisenberg

VP Engineering and Operations

Amir is a manager that prefers focusing on ensuring tasks are completed, a ‘doer’ rather than a ‘talker’.
Throughout his career he managed different aspects related to engineering and process efficacy, striving for higher efficiency in each area.
Amir began at DIR in 2012, serving as the Product Manager for the company’s flagship, Induction Integrity Verification System (I2VS). His leadership in bringing the I2VS to market led to Amir being promoted to position of VP Engineer and Operations.

Prior to DIR, for over a decade, Amir served in a number of critical functions at SCD, SemiConductor Devices. He began as a Process Engineer and rose to the position of overseeing process monitoring and yield improvement and later, managing a Process Engineering Group.
Amir is a Mechanical Engineer. He completed his studies with distinction at Ort Braude, Karmiel.

Dr. Ephi Pinsky

CTO & IP Director

Ephi is a senior physicist with a deep knowledge and almost 4 decades of experience and expertise in the fields of Imaging Science, Photonic, and Optical Technologies. His wide horizons and creativity enable him to find successful, unique and innovative solutions in his expertise fields combined with Image Processing, Machine Vision, and Artificial Inelegance.

Ephi worked previously as an R&D leader and a mentor in the defense industry. He was exposed to and involved in wide range of advanced projects and in applied research. He has dozens of published works and patents. He gains B.Sc.& M.Sc. in Physics from Tel Aviv University and Ph.D. in Physics from the School of Applied Science & Technology of the Hebrew University of Jerusalem
He spent two periods of Sabbatical leaves as a visitor scientist at Kodak Research Labs- Rochester Upstate New York at the late eighties and in 3DV Systems- Israeli startup engaged with a novel idea in 3D real-time imaging at the beginning of this century.

Gabby Klausner

CFO

Gabby has two decades of experience in finance management of global companies in the hi-tech and industrial sectors, in both public and private companies.
Gabby’s experience includes establishing financial work processes, leading ERP system implementations, managing merger & acquisition processes, financial reporting complying with US GAAP, tax reporting and audits.

Prior to joining DIR, Gabby served 3 years as a controller in Qualcomm Israel and prior to that 4 years as Director of finance in Orbit FR Israel. In addition, Gabby has extensive experience in start-up companies. She served as CFO in Acro Inc., a NASDAQ traded start-up company and before that as the controller of CyOptics, a spin-off company from SCD. Gabby started her way in the industry as a deputy controller in SCD.
Gabby, a licensed CPA, holds an MBA from the University of Haifa, and a BA in accounting and economics from Tel Aviv University.

Advisory Board

Susan C. Morris

Pharmaceutical and Supply Chain Consultant

Susan Morris is a pharmaceutical executive with 35 years of knowledge and experience in the pharmaceutical industry. Sue's career has spanned a breadth of major opportunities within Merck and Co. Inc., from heading the North and South American manufacturing sites, to serving as the Chief of Staff to the CEO.

Sue earned a Bachelor of Science degree in Biology from Lehigh University in 1977 and joined Merck and Co.,Inc that same year. She held positions of increasing responsibility throughout her 35 year career at Merck, focused
primarily in the functions of manufacturing. These included operations, sterile processing, quality, supply chain, strategy, budgeting, and lean manufacturing/operations improvement. In her role as Senior Vice President for Manufacturing, Sue had responsibility for 5 sites in the US, as well as sites in Puerto Rico, Mexico, Costa Rica, Brazil, Argentina, and Canada.
Sue led the Respiratory Worldwide Business Strategy Team for Merck from 1998 to 2002, with responsibility for developing the long term strategy for the franchise as well as for overseeing the launch of key respiratory
products to the market.
In 2009 Sue served as the Chief of Staff to the CEO during which time Merck successfully completed the merger and integration of Merck and Schering Plough, doubling the size of the corporation. She later joined the commercial division of the corporation as Senior VP, Global Human Health Operations, where she established a global sales and operations planning process across the sales/marketing, finance, and manufacturing divisions.
Sue has also served on the Board of Directors for the National Association of Manufacturers, as well as on the Board of Directors for The Franklin Science Institute in Philadelphia, PA, USA.

Michael Berelowitz MB.ChB, FCP(SA), FACP

Biopharmaceuticals Consultant

Dr. Michael Berelowitz has enjoyed a 40+ year career in the biomedical sciences across clinical practice of medicine, basic and clinical research and teaching, together with senior responsibilities in administration, budget management and people leadership in academia and pharmaceutical company / industry settings. This diverse experience set has provided Michael with an unusual if not unique insight and understanding of the biopharmaceuticals world and its future.

Michael grew up and received his education in Zimbabwe and South Africa. He attended the University of Cape Town Medical School graduating (MB.ChB) in 1968 and completed his internship, residency training in Internal Medicine (FCP(SA)), and fellowship training in Endocrinology and Metabolism at the affiliated Groote Schuur Hospital.
In 1977 Dr Berelowitz moved to the United States to pursue a career in academic medicine - at the University of Chicago - Michael Reese Hospital (1977-1981), University of Cincinnati College of Medicine (1981-1985) and SUNY
StonyBrook School of Medicine (1985-1996) as Professor of Medicine, Pharmacology and Biophysics where he led the Division of Endocrinology and Metabolism.
in 1996 Michael joined Pfizer Inc and over the course of the next 15 years enjoyed positions of increasing responsibility leading the Diabetes unit, Cardiovascular group, Global Medical organization and finally serving as Senior Vice President and Head of Clinical Development and Medical Affairs in the Specialty Care Business Unit (from 2009 - 2011).
Michael continues to be active in bringing his experiences to bear as a member of the Boards of Directors of the Endocrine Fellows Foundation and Oramed Pharmaceuticals Inc. and on the Scientific Advisory Boards of Oramed
Pharmaceuticals Inc. (Chair since June 2011) and Metacure Ltd Over the years Michael has chaired the Task Force on Research of the New York State Council on Diabetes, served on the board of directors of the American
Diabetes Association and the Clinical Initiatives Committee of the Endocrine Society and on several editorial boards, including The Journal of Clinical Endocrinology and Metabolism and Endocrinology, Reviews in Endocrine and
Metabolic Disorders and Clinical Diabetes.
Dr. Berelowitz has authored and co-authored more than 100 peer-reviewed journal articles and book chapters in the areas of pituitary growth hormone regulation, diabetes and metabolic disorders.

Board of Directors

Mr. Bill Burkoth

Bill Burkoth is currently an Executive Director of Pfizer Ventures, the venture capital arm of Pfizer Inc.

Since joining Pfizer in early 2004, Bill has played an instrumental role in numerous new venture capital investments, including Avid Radiopharmaceuticals (acquired by Eli Lilly), Clovis Oncology (Nasdaq: CLVS), DVS Sciences (acquired by Fluidigm), Evolution Benefits (acquired by Genstar Capital), HandyLab (acquired by Becton Dickinson), and HD Biosciences (acquired by Wuxi AppTec). Bill currently serves on the board of directors of AMRA, Biodesy, DIR Technologies, G-Con Manufacturing, NeuMoDx Molecular, Novocure (Nasdaq: NVCR), Palleon Pharma, and RefleXion Medical. He is also a member of the investment committee of the Investment Fund for Health in Africa (IFHA) and FinHealth Gestão de Recursos S.A. (Rio, Brazil).

Prior to joining Pfizer, Bill worked in Business Development at Galileo Pharmaceuticals and at IntraBiotics Pharmaceuticals. Prior to his roles in business development, Bill was an analyst at Bay City Capital. Mr. Burkoth received a BA in chemistry from Whitman College and an MBA from Columbia Business School.

Mr. Ron Eilat

For the last 12 years, Ron Eilat has served in several positions at Rafael Advanced Defense Systems including: Project Manager and Deputy of a Business Unit Manager. Currently, Mr. Eilat is a M&A Manager in Rafael's Subsidiaries Department.

Prior to joining Rafael, Ron served as the CFO of several hi-tech companies.
Ron holds an Engineering degree from the Technion Institute of Technology in Haifa, Israel and an MBA degree from Washington University in St. Louis, Missouri.

Mr. Roni Mansur

Roni serves as DIR Technologies CEO. Roni is a financial expert and a highly experienced manager and board member. He brings to the table an unusual combination of being comfortable in two worlds: that of statistics and accounting as well as that of entrepreneurship and out of the box thinking.

Roni served as CFO of SCD, SemiConductor Devices for over two decades. During that time he was involved in M&A activities. Roni co-founded CyOptics Inc. and served as a board member for over 12 years. Founded in 1999, the company was acquired in 2013 for $400m.
Before SCD, Roni held several financial positions in Kulicke & Soffa Ltd. and Elscint Ltd.
Roni holds a B.A. in Economics and Statistics from Haifa University and a M.Sc. in Industrial Management from the Technion.

Partners

Pfizer Inc.

Pfizer Inc. is an American global pharmaceutical corporation headquartered in New York City, with its research headquarters in Groton, Connecticut. It is among the world's largest pharmaceutical companies.

Rafael Advanced Defense Systems Ltd.

designs, develops, manufactures and supplies a wide range of high-tech defense systems for air, land, sea and space applications.
Rafael was established as part of the Ministry of Defense over 50 years ago and was incorporated in 2002. Currently, 7% of its sales are invested in R&D. Rafael's know-how is embedded in almost all Israel Defense Forces (IDF) systems in operation today. The company has a special relationship with the IDF, developing products according to the soldiers' specific requirements in the field. Rafael has also formed partnerships with civilian counterparts to develop commercial applications based on its proprietary technology.

SCP Vitalife

is a Life Sciences fund, with an emphasis on medical equipment.
The fund operates from two centers, one in Tel Aviv and the other in Philadelphia, and invests in Israeli and American companies. The Israeli Defense Industry is a source of novel technologies that can often be adapted to provide solutions to significant medical problems. SCP Vitalife is in close contact with this industry, and continually looks for new technologies suitable for the medical field.